Ferreri M, Florent C, Gerard D
Hôpital Saint-Antoine, Service de Psychiatrie, Paris.
Encephale. 2000 Jul-Aug;26(4):58-66.
Among somatoform disorders, pain disorder (DSM IV) appears to be relatively common in general practice and to cause social, psychological, and functional impairment. A previous study conducted by Lemoine (1997) has shown that sulpiride is more effective than placebo in reducing intensity and frequency of pain in this disorder. The aim of our study was to assess safety and efficacy of sulpiride in a large sample of patients under natural conditions of use, in general practice. In a multicenter, open clinical trial, 669 patients (mean age: 47 years +/- 12; male: 245, female: 424) fulfilling the DSM IV criteria for pain disorder (of gastrointestinal localization), were included by 321 general practitioners (GP) and treated for 6 weeks with sulpiride 150 mg/d. Investigators' evaluations were planned at D14 and D42. Furthermore a diary was given to each patient for self evaluation and intercurrent events reporting. The pain was of psychological type in 93% of cases and caused social or working disabilities in 78% of patients. At inclusion the mean score of the Hamilton Anxiety Rating Scale was 18 +/- 8, and the mean score of the depression scale HARD (Humeur, Angoisse, Ralentissement, Danger) was 14.8 +/- 6.4. During the study 7.9% of the patients had at least one adverse event, and 3% of patients were withdrawn for adverse event. Safety assessed with a specific variable (grouping together adverse events' reporting and results of CGI item 3) was good for 88% of patients. The principal criterion of efficacy was the clinician's evaluation of the intensity and frequency of abdominal pain on a four-point scale from 0 (asymptomatic) to 3 (important/continuous) from D0 to D End a decrease in pain intensity (91% of patients) and in pain frequency (89%) was observed as well as in frequency and intensity of related gastroenterological symptoms such as disturbances of bowel movements (79% and 78%), bloated symptoms (88% and 83%), nausea/vomiting (90% and 90%). A similar improvement (p < 0.001) was observed from D0 to End point on the self evaluation parameters (Visual Analogic Scales), assessing pain (mean score D0-D End: 17.1 +/- 15.9), quality of sleep (mean score D0-D End: 27.1 +/- 17.8), activity (mean score D0-D End: 24.4 +/- 18.8), and appetite (mean score D0-D End: 22.6 +/- 16.6). In conclusion these results confirm the usefulness of sulpiride in the treatment of pain disorders a symptomatology known to cause difficulties to GP's in their practice.
在躯体形式障碍中，疼痛障碍（《精神疾病诊断与统计手册》第四版）在全科医疗中似乎相对常见，并会导致社会、心理和功能障碍。勒莫因（1997年）之前进行的一项研究表明，在减轻这种疾病的疼痛强度和频率方面，舒必利比安慰剂更有效。我们研究的目的是在全科医疗的自然使用条件下，评估舒必利在大量患者样本中的安全性和有效性。在一项多中心、开放性临床试验中，321名全科医生纳入了669名符合《精神疾病诊断与统计手册》第四版疼痛障碍（胃肠道定位）标准的患者（平均年龄：47岁±12岁；男性：245名，女性：424名），并用150毫克/天的舒必利治疗6周。计划在第14天和第42天进行研究者评估。此外，还给每位患者一本日记用于自我评估和报告并发事件。93%的病例疼痛属于心理类型，78%的患者存在社会或工作残疾。纳入时，汉密尔顿焦虑评定量表的平均得分为18±8，抑郁量表HARD（情绪、焦虑、迟缓、危险）的平均得分为14.8±6.4。在研究期间，7.9%的患者至少出现一次不良事件，3%的患者因不良事件退出。用一个特定变量评估的安全性（将不良事件报告和临床总体印象量表第3项结果合并）在88%的患者中良好。疗效的主要标准是临床医生从第0天到治疗结束时对腹痛强度和频率进行的四点量表评估（从0分（无症状）到3分（严重/持续）），观察到疼痛强度（91%的患者）、疼痛频率（89%）以及相关胃肠症状的频率和强度如排便紊乱（79%和78%）、腹胀症状（88%和83%）、恶心/呕吐（90%和90%）均有所下降。从第0天到终点，在自我评估参数（视觉模拟量表）上观察到类似的改善（p<0.001），这些参数评估疼痛（第0天至治疗结束时平均得分：17.1±15.9）、睡眠质量（第0天至治疗结束时平均得分：27.1±17.8）、活动（第0天至治疗结束时平均得分：24.4±18.8）和食欲（第0天至治疗结束时平均得分：22.6±16.6）。总之，这些结果证实了舒必利在治疗疼痛障碍方面的有效性，这种症状在全科医生的临床实践中会带来困难。
